Senior Clinical Data Manager

Found in: Resume Library US A2 - 1 week ago

Cambridge Massachusetts, United States AL Solutions Full time
George Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology.

The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and oversight of data management activities of our sponsored clinical trials

They’re interested in bringing in top-tier Data Managers that have a desire to progress within their career. With this role being based on-site x3 days p/w in Cambridge, Massachusetts, you get the opportunity to work alongside some of the most experienced professionals in the region.

Main Responsibilities:

Lead studies as the Senior Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues. May also serve as support for other Lead Clinical Data Managers as needed.

Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure.

Develop or quality control review Data Validation Specifications (DVS) documents.

Program edit checks and other system functions within EDC as needed.

Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.

Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans.

Responsible for data cleaning activities including data review, query generation and management, and development of study metrics either through direct action or delegation to other team members. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.

Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.).

Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation

Partner with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities.

Requirements:

Bachelor’s degree in a related field & 5 years of relevant experience required; at least 3 years experience in clinical data management in a clinical research setting also required.

2 years of experience in leading project teams required.

Certifications and/or courses completed in Medidata Rave Study Design and Build Essentials strongly preferred.

Overall understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

Skilled in use of computer technology, including clinical trial databases and applications (g., IBM Clinical Development, Medidata RaveX) and ability to learn new applications

Detailed understanding of project planning and management methods.

Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes.

Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

Ability to work in different projects with different priorities and act as team mentor and provide data management expertise.

How To Apply:

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.

George Higginson

AL Solutions

  • Senior Clinical Data Manager

    Found in: Resume Library US A2 - 1 week ago

    Cambridge, Massachusetts, United States AL Solutions Full time

    Ashley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team. Position Overview: Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In this role, you will play a...

  • Senior Clinical Data Manager

    2 weeks ago

    Cambridge, United States AL Solutions Full time

    Job DescriptionJob DescriptionAshley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team.Position Overview:Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In...

  • Senior Clinical Data Manager

    Found in: Appcast Linkedin GBL C2 - 3 days ago

    Cambridge, United States AL Solutions Full time

    Ashley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team.Position Overview:Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In this role, you will play a...

  • Senior Clinical Data Manager

    1 week ago

    Cambridge, United States AL Solutions Full time

    Job DescriptionJob DescriptionGeorge Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology. The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and...

  • Senior Clinical Data Manager

    Found in: Appcast Linkedin GBL C2 - 3 days ago

    Cambridge, United States AL Solutions Full time

    George Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology.The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and oversight of data management...

  • Senior Director, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

  • Senior Manager, Statistical Programming

    Found in: Resume Library US A2 - 12 hours ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job Description The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to...

  • Senior Director, Clinical Data Management

    1 week ago

    Cambridge, United States Editas Medicine Full time

    Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....

  • Sr. Manager, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description We are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s). This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office....

  • Manager Clinical Data Management

    4 days ago

    Cambridge, United States ClinLab Staffing Full time

    MANAGER DATA MANAGEMENTCambridge, MA, USRESPONSIBILITIESManage and supervise a team of Clinical Data Managers (CDMs)Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex...

  • Manager Clinical Data Management

    Found in: Appcast Linkedin GBL C2 - 5 days ago

    Cambridge, United States ClinLab Staffing Full time

    MANAGER DATA MANAGEMENTCambridge, MA, USRESPONSIBILITIESManage and supervise a team of Clinical Data Managers (CDMs)Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex...

  • Senior Manager, Quality

    Found in: Resume Library US A2 - 1 week ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job Description Senior Manager, Quality provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the team tasked with product development, the position serves as a Quality and compliance business partner, engaging with multiple...

  • Manager, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Deciphera...

  • Manager of Data Management

    Found in: Appcast US C2 - 1 week ago

    Cambridge, United States SRG Full time

    SRG, the leader in the Life Sciences human capital industry, is looking for a full-time Manager of Clinical Data Management for a Global Pharmaceutical CRO located in Cambridge, Mass. This role is responsible for managing and supervising a team of Clinical Data Managers (CDMs). Oversee each project assigned to the team.Responsibilities include, but are not...

  • Manager of Data Management

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Cambridge, United States SRG Full time

    SRG, the leader in the Life Sciences human capital industry, is looking for a full-time Manager of Clinical Data Management for a Global Pharmaceutical CRO located in Cambridge, Mass. This role is responsible for managing and supervising a team of Clinical Data Managers (CDMs). Oversee each project assigned to the team.Responsibilities include, but are not...

  • Senior Director of Data Management

    2 weeks ago

    Cambridge, United States EPM Scientific Full time

    Senior Director of Data Management and ReportingCambridge, MA (hybrid) I am partnered with a large pharmaceutical company looking for an experienced commercial data management professional to serve as the Data Steward and to develop and lead data strategy and governance processes. Key Responsibilities:Direct the Data Strategy and Management team to develop...

  • Senior Director of Data Management

    Found in: Appcast US C2 - 1 week ago

    Cambridge, United States EPM Scientific Full time

    Senior Director of Data Management and ReportingCambridge, MA (hybrid) I am partnered with a large pharmaceutical company looking for an experienced commercial data management professional to serve as the Data Steward and to develop and lead data strategy and governance processes. Key Responsibilities:Direct the Data Strategy and Management team to develop...

  • Senior Director of Data Management

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Cambridge, United States EPM Scientific Full time

    Senior Director of Data Management and ReportingCambridge, MA (hybrid) I am partnered with a large pharmaceutical company looking for an experienced commercial data management professional to serve as the Data Steward and to develop and lead data strategy and governance processes. Key Responsibilities:Direct the Data Strategy and Management team to develop...

  • Senior Manager, Clinical Supply Chain

    Found in: Talent US C2 - 2 weeks ago

    Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Clinical Supply Chain  Who we are: is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with...

  • Senior Data Engineer

    3 days ago

    Cambridge, United States CareerBuilder Full time

    Job Description Senior Data Engineer Position Summary As a Senior Data Engineer at Harbinger Health, you will develop and refine our bioinformatics pipeline, this work is essential for the automation and processing of patient samples. Your contributions will include implementing and sustaining sophisticated engineering solutions and ensuring that these...